UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024834 |
|---|---|
| Receipt number | R000026963 |
| Scientific Title | Nursing interventions focusing on a parent's attitudes towards child rearing to improve the self-care of infants and schoolchildren with congenital heart disease |
| Date of disclosure of the study information | 2016/11/15 |
| Last modified on | 2018/05/27 18:35:58 |
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Basic information
Public title
Nursing interventions focusing on a parent's attitudes towards child rearing to improve the self-care of infants and schoolchildren with congenital heart disease
Acronym
Nursing interventions focusing on a parent's attitudes towards child rearing to improve the self-care of infants and schoolchildren with congenital heart disease
Scientific Title
Nursing interventions focusing on a parent's attitudes towards child rearing to improve the self-care of infants and schoolchildren with congenital heart disease
Scientific Title:Acronym
Nursing interventions focusing on a parent's attitudes towards child rearing to improve the self-care of infants and schoolchildren with congenital heart disease
Region
| Japan |
Condition
Condition
congenital heart disease
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of maternally targeted nursing interventions in improving the self-care of infants and schoolchildren with congenital heart disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the perceptions of parent
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
We provided nursing interventions for a patient's parent: before surgery and before discharge from hospital.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a parent whose children were scheduled for surgery for cyanotic congenital heart disease and who met all of the following criteria were included:
1. willing to explain the treatment and recuperation activities to their children and to have the children do what they could by themselves
2. able to read and write Japanese
3. children aged between 2 years 10 months and 9 years
4. children needing long-term postoperative self-care
5. children able to communicate with others
Key exclusion criteria
a parent whose children had undergone emergency surgery
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Handa / Keiko Ninomiya |
Organization
Kobe City College of Nursing
Division name
Doctoral Program
Zip code
Address
3-4 Gakuennisimachi,Nisiku, Kobe city, Hyogo, Japan
TEL
078-794-8080
d1404@st.kobe-ccn.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromi Handa |
Organization
Okayama University Hospital
Division name
Nursing Department
Zip code
Address
2-5-1 Sikatacho, Kitaku, Okayama city, Okayama
TEL
086-223-7151
Homepage URL
handa-h1@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Suspended
Date of protocol fixation
| 2016 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 14 | Day |
Last modified on
| 2018 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026963
